Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103582
KELYNIAM CUSTOM SKULL IMPLANT (CSI) · Kelyniam Global, Inc. · decided 2011-04-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580026951 |
| Kelyniam CSI | PEEK-IM1003 | KELYNIAM GLOBAL, INC. | GXN | 00817580026388 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580026005 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580025121 |
| Kelyniam CSI | PEEK-IM1003 | KELYNIAM GLOBAL, INC. | GXN | 00817580023714 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125924903 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125922664 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125921780 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125921155 |
| KELYNIAM CSI | PEEK-IM1002 | KELYNIAM GLOBAL, INC. | GXN | 00810125921025 |
| Kelyniam CSI | PEEK-IM1002 | KELYNIAM GLOBAL, INC. | GXN | 00817580028535 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580026807 |
| Kelyniam CSI | PEEK-IM1002 | KELYNIAM GLOBAL, INC. | GXN | 00817580026623 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580024131 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580023042 |
| Kelyniam CSI | PEEK-IM1003 | KELYNIAM GLOBAL, INC. | GXN | 00817580022908 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580021536 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580020171 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125928017 |
| KELYNIAM CSI | PEEK-IM1002 | KELYNIAM GLOBAL, INC. | GXN | 00810125923838 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125923098 |
| KELYNIAM CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00810125921230 |
| KELYNIAM CSI | PEEK-IM1001 | KELYNIAM GLOBAL, INC. | GXN | 00810125921131 |
| Kelyniam CSI | PEEK-IM1001 | KELYNIAM GLOBAL, INC. | GXN | 00817580029877 |
| Kelyniam CSI | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GXN | 00817580026098 |